Individualized Exercise Training Based on the Heart Rate Variability in Coronary Heart Disease Patient

NCT04971707 | Completed DMC

• 1 other identifier: 2021-2897
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this project is to assess the effectiveness of a new modality of prescribing the intensity of physical exercise in cardiovascular rehabilitation programs according to physiological criteria (heart rate variability measured every morning) in comparison to a standard non-individualized program.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Diseases; Cardiac rehabilitation; exercise training; heart rate variability; cognitive performance

Outcome Measures

Primary Outcomes (2)

• Change in cardiorespiratory fitness

  Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min))

  Baseline and post-intervention at 3 months

• Responders and non-responders proportion

  Proportion in each group (%) Responders will be defined as an increased of 5% of VO2max.

  Baseline and post-intervention at 3 months

Secondary Outcomes (8)

• Parasympathetic activity

  Baseline and post-intervention at 3 months

• Parasympathetic activity

  Baseline and post-intervention at 3 months

• heart rate variability

  Baseline and post-intervention at 3 months

• Baroreflex gain

  Baseline and post-intervention at 3 months

• Change in general cognitive functioning

  Baseline and post-intervention at 3 months

Other Outcomes (3)

• Change in anxiety

  Baseline and post-intervention at 3 months

• Change in depressive symptoms

  Baseline and post-intervention at 3 months

• Change in sleep quality

  Baseline and post-intervention at 3 months

Study Arms (2)

standard exercise training

ACTIVE COMPARATOR

The physical exercises intervention will include a standardized aerobic exercises training, three sessions per week for 3 months.

Other: Standardized exercise training

HRV-guided exercise training

EXPERIMENTAL

The physical exercises intervention will include an individualized aerobic exercises training, three sessions per week for 3 months.

Other: HRV-guided exercise training

Interventions

Standardized exercise training OTHER

HRV index will be measured every morning during 5 min. This group will benefit from the standard cardiovascular rehabilitation program combining both continuous moderate exercise sessions (MICT) and high intensity interval exercise sessions (HIIT). MICT sessions will be performed 2 times per week and HIIT sessions will be performed once a week.

standard exercise training

HRV-guided exercise training OTHER

HRV index will be measured every morning during 5 min. This group will benefit from the individualized cardiovascular rehabilitation program. Daily exercise (MICT, HIIT, or active recovery) will be prescribed according to the HRV-index measured on the morning of the session.

HRV-guided exercise training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Coronary artery disease patient from the Montreal Heart Institute
• Age\> 18 years old
• Referred to the EPIC center in a cardiovascular rehabilitation program due to stable angina pectoris, acute coronary syndrome (with or without ST segment elevation) or after complete coronary revascularization (primary or elective) by Percutaneous Coronary Intervention.
• Able to perform a maximal cardiopulmonary exercise stress test in accordance with current cardiovascular rehabilitation recommendations.
• Able to read, understand and sign the information and consent form.

You may not qualify if:

• Any absolute and relative contraindication to the maximal exercise test and / or physical activity.
• Recent cardiovascular events (cardiac decompensation or treatment with positive inotropic drugs or angioplasty less than 10 days, cardiac surgery less than 1 month, valve disease requiring surgical correction, active myopericarditis, severe ventricular arrhythmias not stabilized under treatment).
• Revascularization by coronary artery bypass grafting
• Atrial fibrillation
• Renal failure
• Heart failure
• Diabetes

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (1)

Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute

Montreal, Quebec, H1T1N6, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Louis Bherer, PhD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This clinical trial is a double-blinded study. Patients, and research personnel performing the outcome assessments and investigators will be blinded to group allocation. Only the kinesiologists will be aware of the group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate scientific director, Direction of prevention, Montreal Heart Institute

Model Details: parallel assignment, 2 groups (1:1)

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 21, 2021
• Study Start: August 1, 2021
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)